Senior Regulatory Affairs Specialist ( Medical Device)
|Job Id: 20428|
|Job Type: Permanent|
|Industry: MEDICAL DEVICES|
|Worksite Location: Headquarters office|
|Location: Fremont, CA 94539|
Join a leader that is renowned throughout the medical device industry as well as the tech world!
They are super passionate about creating innovative products that are life-transforming.
They’re also passionate about hiring the best: They’re looking to hire a “go-getting” and “out-of-the-box” thinking Senior Regulatory Affairs Specialist.
ABOUT THE POSITION…
In the role of Senior Regulatory Affairs Specialist, you will manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies. The Senior Regulatory Affairs Specialist will also manage activities such as audits, regulatory agency inspections, or product recalls.
THE RIGHT CANDIDATE HAS…
- Bachelor’s degree in a related field of study or equivalent.
- 5+ years of related experience.
- Strong understanding of state, local, federal, and international regulations.
- Demonstrated project management skills.
- Experience with internal audits and support of third-party audits as necessary.
- Hands on and knowledge of MDD/MDR & Post-market surveillance.
- Strong knowledge and understanding of UDI and FDA portal.
- Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission, and maintenance.
- Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources.
- Regulatory Affairs certification preferred.
WHAT YOU’LL RECEIVE…
- Attractive salary + bonus
- Rich comprehensive benefits package
- Relocation benefits
- A culture of integrity, latest technologies, and top talent
We’re Interviewing NOW!